Senior Director, Head of Quality Control (QC) Vaccine Development
for section headings (About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)
2. Use - for lists of duties/requirements/benefits, and
for prose
3. Do NOT repeat the job title as a heading
4. Do NOT put Job ID / requisition numbers as headings
5. Preserve ALL substantive information
6. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions
7. Include a section ONLY when the posting has real, specific content for it
8. Never emit a heading followed by filler/placeholder text
9. Never create Pay/Schedule/Benefits sections unless the posting actually states them
10. Output ONLY the HTML fragment — no /, no markdown code fences
Let me analyze the job posting content:
- "Why Sabin" - mission statement, could be "About the role" or similar
- "Position Summary" - overview of the role
- "Key Responsibilities" - detailed responsibilities with subsections
- "Requirements" - education, experience, skills
- "Other" - background check, references, education verification
- "Work Authorization" - visa sponsorship info
- "Salary Description" - salary range and benefits
I need to structure this into appropriate sections. The posting has:
- About the role (mission, position summary)
- Responsibilities (detailed with subsections)
- Requirements (education, experience, skills)
- Benefits (salary range, benefits package)
- Work Authorization (visa sponsorship)
I should not include EEO, recruiter notice, etc. as they are boilerplate.
Let me create the HTML structure:
About the role
Why Sabin: Our mission is to make vaccines more accessible, enable innovation, and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
Position Summary: We are seeking a dedicated and mission-driven professional to join our team in advancing vaccine research, development, and global immunization efforts. This role supports critical initiatives aimed at improving public health outcomes through the discovery, evaluation, and delivery of safe and effective vaccines. The successful candidate will contribute to cross-functional projects involving scientific research, clinical development, regulatory compliance, nonclinical studies, and global health strategy. Working closely with internal teams and external partners, the candidate will help ensure the timely progression of vaccine programs from early-stage research through to implementation in low-, middle-, and high-income countries. This position requires strong analytical skills, scientific curiosity, and a deep commitment to equity in global health.
Responsibilities
- The QC Program Implementation Lead will establish Sabin's first dedicated QC capability by designing and implementing a phase-appropriate, current Good Manufacturing Practice (cGMP)-compliant QC framework that supports the transition from Phase 2 through Phase 3, Process Performance Qualification (PPQ), Biologics License Application (BLA), and commercialization.
- Working closely with Sabin's existing Analytical Sciences and CMC Quality team and external laboratories/Contract Development and Manufacturing Organizations (CDMOs), the role will establish the QC operating model, governance, processes, technical standards, and interfaces needed to ensure reliable and compliant drug substance and drug product testing.
GMP QC Program & Governance
- Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory, and Program Management to establish and maintain appropriate governance and sponsor oversight of laboratories and CDMOs performing testing on Sabin's behalf.
- Define QC roles, decision rights, handoffs, documentation requirements, and escalation pathways within Sabin's existing program governance and applicable quality agreements.
- Support CMC Analytical Sciences to establish phase-appropriate QC strategies and standards aligned with product development, control strategy, regulatory requirements, and commercialization objectives.
- QC oversight of analytical method lifecycle management, specifications, release and stability testing, reference standards and critical reagents for release testing, contract testing laboratory oversight investigations, and inspection readiness.
Analytical & Technical QC Oversight
- Provide sponsor-level QC oversight of analytical PPQ readiness, including implementation and ongoing performance of validated in-process, release, characterization, and stability methods supporting drug substance and drug product.
- Partner with Analytical Sciences and external partners to ensure appropriate method transfer, qualification/validation, implementation, lifecycle management, and ongoing technical support.
- Provide technical leadership and risk-based decision-making for significant analytical and QC issues and their potential product or regulatory impact.
- Review QC readiness and testing documentation supporting PPQ batches, including specifications, sampling and testing requirements, reference-standard and critical-reagent availability, method status, laboratory readiness, data review, investigations, certificates of analysis, and stability commitments.
- Provide QC leadership for significant out-of-specification (OOS)/out-of-trend (OOT) results, deviations, and other QC-related quality risks, including assessment, escalation, and resolution.
- Identify and escalate data integrity concerns through Sabin's enterprise quality system in partnership with CMC Quality.
External Laboratory & CDMO Oversight
- Ensure quality agreements clearly define responsibilities for testing, data review and transfer, records retention, audit access, investigations, change notification, reference standards, sample management, stability activities, and escalation of significant events.
- Ensure external QC activities are appropriately qualified, controlled, monitored, and aligned with GMP requirements, quality agreements, data integrity expectations, and regulatory commitments.
- Oversee vendor performance, testing activities, QC documentation, investigations, changes, and escalation of significant risks or issues.
Quality, Compliance & Readiness
- Establish and maintain a fit-for-purpose QC framework, procedures, and quality systems supporting outsourced testing activities.
- Provide QC leadership for significant OOS/OOT results, deviations, data integrity concerns, and other quality risks, including assessment, escalation, and resolution.
- Support regulatory and US Government (USG) submissions, audits, and inspections by ensuring that QC data and supporting records are complete, accurate, attributable, traceable to source documentation, appropriately reviewed, and consistent across analytical reports, certificates of analysis, stability reports, regulatory submissions, and other required deliverables.
QC Leadership & Program Execution
- Serve as the QC representative on CMC and cross-functional program teams, ensuring QC requirements, dependencies, risks, and deliverables are integrated into program planning.
- Provide strategic and technical leadership across QC activities, applying risk-based decision-making to address evolving program needs and unexpected issues.
- Partner across functions and with external organizations to establish clear accountability, communication, and escalation pathways throughout Phase, PPQ, BLA, and commercialization.
QC Capability & Continuous Improvement
- Develop and evolve Sabin's outsourced QC capability, including external laboratory/CDMO relationships, technical expertise, systems, governance, and future organizational needs.
- Establish appropriate performance metrics and governance mechanisms to assess the effectiveness of the external QC network, identify risks, and drive continuous improvement.
- Perform other duties as assigned.
Requirements
- Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline; advanced degree preferred.
- 14+ years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment, including experience supporting late-stage development and/or commercial manufacturing.
- Experience supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency, is preferred.
- Experience with analytical PPQ readiness, vaccine release and stability testing, sponsor oversight of external testing laboratories, and preparing or reviewing QC data for regulatory submissions is strongly preferred.
- Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing environment is preferred.
- Demonstrated experience overseeing outsourced QC activities, analytical laboratories, CDMOs, Contract Research Organizations (CROs), or other external testing organizations within a GMP environment.
- Strong knowledge of GMP QC principles, analytical method lifecycle management, method transfer, qualification/validation, specifications, stability, and release testing, OOS/OOT investigations, data integrity, and inspection readiness; vaccine experience strongly preferred.
- Demonstrated ability to establish QC governance and oversight within a virtual or matrixed organization and effectively manage technical relationships with external partners.
- Strong risk-based decision-making, problem-solving, and communication skills, with the ability to address unexpected QC issues and clearly communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner audiences.
- Demonstrated ability to lead through ambiguity and changing program needs, with a practical, hands-on approach to establishing processes, managing external partners, and building a fit-for-purpose QC program.
- Experience in both development/start-up and commercial GMP environments is strongly preferred.
Other Requirements
- Subject to a criminal background investigation
- Request for three professional references
- Verification of education/degrees
Work Authorization
This position is not eligible for visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.
Pay & Benefits
Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation, and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $216,000 to $243,000. The exact compensation may vary based on skills, experience, training, and certifications/degree.
As a grant-funded organization, Sabin actively seeks funding for existing and new programs. Sabin provides a comprehensive benefits package for eligible employees, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.
I should note that the user said "Do NOT repeat the job title as a heading (the page already shows it)" - the job title isn't explicitly given in the text, but "QC Program Implementation Lead" appears in the responsibilities. I won't use that as a heading.
Also, the user said "use for section headings" and "Prefer a few substantive sections over many thin ones." I have several subsections under Responsibilities - should I use h4 for those? The instruction says "use for section headings" but doesn't forbid h4 for subsections. However, to keep it simple and follow "Prefer a few substantive sections", maybe I should keep the responsibilities as one section with bullet points that include the subsection titles as bold text or just as part of the bullets. But the content is very detailed with clear subsections.
for prose 3. Do NOT repeat the job title as a heading 4. Do NOT put Job ID / requisition numbers as headings 5. Preserve ALL substantive information 6. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions 7. Include a section ONLY when the posting has real, specific content for it 8. Never emit a heading followed by filler/placeholder text 9. Never create Pay/Schedule/Benefits sections unless the posting actually states them 10. Output ONLY the HTML fragment — no /, no markdown code fences Let me analyze the job posting content: - "Why Sabin" - mission statement, could be "About the role" or similar - "Position Summary" - overview of the role - "Key Responsibilities" - detailed responsibilities with subsections - "Requirements" - education, experience, skills - "Other" - background check, references, education verification - "Work Authorization" - visa sponsorship info - "Salary Description" - salary range and benefits I need to structure this into appropriate sections. The posting has: - About the role (mission, position summary) - Responsibilities (detailed with subsections) - Requirements (education, experience, skills) - Benefits (salary range, benefits package) - Work Authorization (visa sponsorship) I should not include EEO, recruiter notice, etc. as they are boilerplate. Let me create the HTML structure:
About the role
Why Sabin: Our mission is to make vaccines more accessible, enable innovation, and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
Position Summary: We are seeking a dedicated and mission-driven professional to join our team in advancing vaccine research, development, and global immunization efforts. This role supports critical initiatives aimed at improving public health outcomes through the discovery, evaluation, and delivery of safe and effective vaccines. The successful candidate will contribute to cross-functional projects involving scientific research, clinical development, regulatory compliance, nonclinical studies, and global health strategy. Working closely with internal teams and external partners, the candidate will help ensure the timely progression of vaccine programs from early-stage research through to implementation in low-, middle-, and high-income countries. This position requires strong analytical skills, scientific curiosity, and a deep commitment to equity in global health.
Responsibilities
- The QC Program Implementation Lead will establish Sabin's first dedicated QC capability by designing and implementing a phase-appropriate, current Good Manufacturing Practice (cGMP)-compliant QC framework that supports the transition from Phase 2 through Phase 3, Process Performance Qualification (PPQ), Biologics License Application (BLA), and commercialization.
- Working closely with Sabin's existing Analytical Sciences and CMC Quality team and external laboratories/Contract Development and Manufacturing Organizations (CDMOs), the role will establish the QC operating model, governance, processes, technical standards, and interfaces needed to ensure reliable and compliant drug substance and drug product testing.
GMP QC Program & Governance
- Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory, and Program Management to establish and maintain appropriate governance and sponsor oversight of laboratories and CDMOs performing testing on Sabin's behalf.
- Define QC roles, decision rights, handoffs, documentation requirements, and escalation pathways within Sabin's existing program governance and applicable quality agreements.
- Support CMC Analytical Sciences to establish phase-appropriate QC strategies and standards aligned with product development, control strategy, regulatory requirements, and commercialization objectives.
- QC oversight of analytical method lifecycle management, specifications, release and stability testing, reference standards and critical reagents for release testing, contract testing laboratory oversight investigations, and inspection readiness.
Analytical & Technical QC Oversight
- Provide sponsor-level QC oversight of analytical PPQ readiness, including implementation and ongoing performance of validated in-process, release, characterization, and stability methods supporting drug substance and drug product.
- Partner with Analytical Sciences and external partners to ensure appropriate method transfer, qualification/validation, implementation, lifecycle management, and ongoing technical support.
- Provide technical leadership and risk-based decision-making for significant analytical and QC issues and their potential product or regulatory impact.
- Review QC readiness and testing documentation supporting PPQ batches, including specifications, sampling and testing requirements, reference-standard and critical-reagent availability, method status, laboratory readiness, data review, investigations, certificates of analysis, and stability commitments.
- Provide QC leadership for significant out-of-specification (OOS)/out-of-trend (OOT) results, deviations, and other QC-related quality risks, including assessment, escalation, and resolution.
- Identify and escalate data integrity concerns through Sabin's enterprise quality system in partnership with CMC Quality.
External Laboratory & CDMO Oversight
- Ensure quality agreements clearly define responsibilities for testing, data review and transfer, records retention, audit access, investigations, change notification, reference standards, sample management, stability activities, and escalation of significant events.
- Ensure external QC activities are appropriately qualified, controlled, monitored, and aligned with GMP requirements, quality agreements, data integrity expectations, and regulatory commitments.
- Oversee vendor performance, testing activities, QC documentation, investigations, changes, and escalation of significant risks or issues.
Quality, Compliance & Readiness
- Establish and maintain a fit-for-purpose QC framework, procedures, and quality systems supporting outsourced testing activities.
- Provide QC leadership for significant OOS/OOT results, deviations, data integrity concerns, and other quality risks, including assessment, escalation, and resolution.
- Support regulatory and US Government (USG) submissions, audits, and inspections by ensuring that QC data and supporting records are complete, accurate, attributable, traceable to source documentation, appropriately reviewed, and consistent across analytical reports, certificates of analysis, stability reports, regulatory submissions, and other required deliverables.
QC Leadership & Program Execution
- Serve as the QC representative on CMC and cross-functional program teams, ensuring QC requirements, dependencies, risks, and deliverables are integrated into program planning.
- Provide strategic and technical leadership across QC activities, applying risk-based decision-making to address evolving program needs and unexpected issues.
- Partner across functions and with external organizations to establish clear accountability, communication, and escalation pathways throughout Phase, PPQ, BLA, and commercialization.
QC Capability & Continuous Improvement
- Develop and evolve Sabin's outsourced QC capability, including external laboratory/CDMO relationships, technical expertise, systems, governance, and future organizational needs.
- Establish appropriate performance metrics and governance mechanisms to assess the effectiveness of the external QC network, identify risks, and drive continuous improvement.
- Perform other duties as assigned.
Requirements
- Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline; advanced degree preferred.
- 14+ years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment, including experience supporting late-stage development and/or commercial manufacturing.
- Experience supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency, is preferred.
- Experience with analytical PPQ readiness, vaccine release and stability testing, sponsor oversight of external testing laboratories, and preparing or reviewing QC data for regulatory submissions is strongly preferred.
- Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing environment is preferred.
- Demonstrated experience overseeing outsourced QC activities, analytical laboratories, CDMOs, Contract Research Organizations (CROs), or other external testing organizations within a GMP environment.
- Strong knowledge of GMP QC principles, analytical method lifecycle management, method transfer, qualification/validation, specifications, stability, and release testing, OOS/OOT investigations, data integrity, and inspection readiness; vaccine experience strongly preferred.
- Demonstrated ability to establish QC governance and oversight within a virtual or matrixed organization and effectively manage technical relationships with external partners.
- Strong risk-based decision-making, problem-solving, and communication skills, with the ability to address unexpected QC issues and clearly communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner audiences.
- Demonstrated ability to lead through ambiguity and changing program needs, with a practical, hands-on approach to establishing processes, managing external partners, and building a fit-for-purpose QC program.
- Experience in both development/start-up and commercial GMP environments is strongly preferred.
Other Requirements
- Subject to a criminal background investigation
- Request for three professional references
- Verification of education/degrees
Work Authorization
This position is not eligible for visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.
Pay & Benefits
Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation, and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $216,000 to $243,000. The exact compensation may vary based on skills, experience, training, and certifications/degree.
As a grant-funded organization, Sabin actively seeks funding for existing and new programs. Sabin provides a comprehensive benefits package for eligible employees, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.
I should note that the user said "Do NOT repeat the job title as a heading (the page already shows it)" - the job title isn't explicitly given in the text, but "QC Program Implementation Lead" appears in the responsibilities. I won't use that as a heading. Also, the user said "use